Nordic Everolimus (Certican) Trial in Heart and Lung Transplantation

PHASE4CompletedINTERVENTIONAL
Enrollment

282

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

February 28, 2010

Study Completion Date

February 28, 2010

Conditions
Disorder Related to Cardiac Transplantation
Interventions
DRUG

Everolimus

0.75-1.5 mg twice daily. At the week 1 visit and thereafter, the dose was adjusted to target blood concentration in the range 3-8 ng/mL.

DRUG

Mycophenolic acid (MPA)/azathioprine (AZA)

In the standard CNI arm, all immunosuppressants including (MPA) and azathioprine (AZA) continued unchanged as per local practice.

DRUG

Calcineurin inhibitors (CNI)

Calcineurin inhibitors include cyclosporine, pimecrolimus, and tacrolimus.

DRUG

Steroids

Steroid treatment was according to local practice. If steroids were given, the baseline dose of prednisone or equivalent was to be kept unchanged for all treatment groups for the total study duration, unless a medical condition dictated a change.

Trial Locations (6)

2100

Novartis Investigative Site, Copenhagen

22185

Novartis Investigative Site, Lund

DK-8200

Novartis Investigative Site, Aarhus

Unknown

Novartis Investigative Site, Oslo

413 45

Novartis Investigative Site, Gothenburg

581 85

Novartis Investigative Site, Linköping

Sponsors
All Listed Sponsors
lead

Novartis Pharmaceuticals

INDUSTRY